A CONTROLLED EVALUATION OF THE EFFICACY AND SAFETY OF LOTEPREDNOL ETABONATE IN THE PROPHYLACTIC TREATMENT OF SEASONAL ALLERGIC CONJUNCTIVITIS

PURPOSE: To evaluate the efficacy and safety of loteprednol etabonate 0.5% as prophylactic treatment for the ocular signs and symptoms of se asonal allergic conjunctivitis. METHODS: In this randomized, double-ma sked, placebo-controlled, parallel study, 293 adults with history of s easonal allergic conjunctivitis were treated with either loteprednol e tabonate or vehicle (placebo) four times daily, beginning before the o nset of the allergy season and continuing for 6 weeks. The primary eff icacy measure was a primary composite score (sum of itching and bulbar conjunctival injection scores). Supportive efficacy measures were the investigator global assessment and a secondary composite score (sum o f tearing, erythema, chemosis, and discomfort scores), all calculated during the 21-day peak pollen season. RESULTS: The proportion of patie nts who never developed moderate or severe signs and symptoms of aller gy during the peak pollen season in the loteprednol etabonate treatmen t group was greater than that in the placebo group, For the primary co mposite score, this efficacy criterion was reached by 94% of patients (136/145) in the loteprednol etabonate group and 78% of patients (111/ 143) in the placebo group (P =.001). The magnitude of effect was simil ar for the investigator global assessment (86% [118/138] vs 64% [87/13 7]; P < .001) and, although not statistically significant, the seconda ry composite score (77% [112/145] vs 68% [97/143]; P = .092), None of the loteprednol etabonate-treated patients had an intraocular pressure increase of 10 mm Hg or more, whereas two placebo patients did. CONCL USIONS: Loteprednol etabonate is generally effective in prophylaxis of seasonal allergic conjunctivitis and has an acceptable safety profile .